Thermo Scientific PHARM-TROL Count Precision Size Standards
Document the reproducibility of a particle counter by permitting a continuous record of its performance.
Manufacturer: Thermo Scientific CSBX
Document the reproducibility of a particle counter by permitting a continuous record of its performance with Thermo Scientific PHARM-TROL Count Precision Size Standards, ready-to-use precision standards designed for regular use in liquid particle counters for USP <788> and <789> verification. Data is documented for internal or customer audits by using a NIST-traceable microsphere suspension with a known concentration.
- Contains NIST-traceable size standards with a measured particle count
- Developed for manufacturers of parenteral drugs and ophthalmic solutions seeking interim verification of USP <788> and <789> verification (Particulate Matter in Injections and Particulate Matter in Opthalmic Solutions)
- Particle diameters traceable to the Standard Meter through the National Institute of Standards and Technology
- Prepared with the same exacting procedures as the USP Count Reference Standard, providing process control data for particle counting consistency and verification of size calibration
|Contains trace amount of surfactant|
|3800 particles/mL ± 15%|
|Used by manufatures of parenteral drugs and ophthalmic solutions who are seeking interim verification of USP <788> and <789>.|
|15.0 ± 0.2µm|
|20 x 25mL bottles|
|Unless otherwise stated, refrigerate 2° to 8deg;C product when not in use but do not freeze. Store upright and keep bottle tightly sealed. Mix product with gentle inversion by hand or vortex mixer.|
|Polystyrene microspheres in water|
|15.0μm ± 0.2μm|
|Certificate of Calibration and Traceability to NIST|
|1.59 at 589nm (25°C)|
|Product stable for a minimum of 12 months|
|Count Control Particles|
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